Cempra Inc (NASDAQ:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, announced first patient dosing in a Phase 2 clinical trial exploring the use of solithromycin in nonalcoholic steatohepatitis (NASH). Inflammation plays a key role in the progression of NASH, and the immunomodulatory and anti-NASH activity that has been observed with solithromycin in a murine diabetic NASH model may provide a treatment benefit to patients.
“The commencement of this clinical trial represents an important potential step in furthering our understanding of solithromycin’s mechanism of action beyond anti-bacterial effects,” stated Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. “There is a great need to develop medicines that target the hepatic inflammation caused by NASH and an effective immunomodulatory treatment may reduce disease progression in this serious condition.”
Phase 2 NASH Clinical Trial Design
NASH occurs in approximately 10% to 20% of patients with nonalcoholic fatty liver disease (NAFLD) and increases the risk for development of hepatic complications such as cirrhosis and hepatocellular carcinoma. This Phase 2 open label study will enroll up to 15 patients with NASH without cirrhosis between 18 and 70 years of age. Patients on study will receive 400 mg (2x 200 mg capsules) of solithromycin once daily for 13 weeks. All patients will undergo a liver biopsy at baseline and upon completion of the study. The primary efficacy measure will be change in liver histology as measured by the NAFLD Activity Score (NAS). Fibrosis, ballooning degeneration, and markers of liver inflammation will also be evaluated, along with safety and tolerability. The trial is expected to complete patient enrollment by the end of 2016. (Original Source)
Shares of Cempra closed yesterday at $28.94, down $2.19 or -7.04%. CEMP has a 1-year high of $46.99 and a 1-year low of $15.43. The stock’s 50-day moving average is $30.40 and its 200-day moving average is $32.61.
On the ratings front, Cempra has been the subject of a number of recent research reports. In a report issued on December 21, Needham analyst Alan Carr maintained a Buy rating on CEMP, with a price target of $48, which represents a potential upside of 65.9% from where the stock is currently trading. Separately, on November 16, Morgan Stanley’s Andrew Berens upgraded the stock to Buy and has a price target of $38.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Alan Carr and Andrew Berens have a total average return of 23.9% and 15.5% respectively. Carr has a success rate of 53.6% and is ranked #33 out of 3648 analysts, while Berens has a success rate of 78.3% and is ranked #470.
Overall, one research analyst has assigned a Hold rating and 8 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $42.00 which is 45.1% above where the stock closed yesterday.
Cempra Inc is a clinical-stage pharmaceutical company. It develops antibiotics for acute care & community settings to meet critical medical needs in treatment of bacterial infectious diseases, respiratory tract & chronic staphylococcal infections.